AEs and trough FEV1 changes from baseline by subgroup
AEs n (%)PBO + FORSequential(n=59)PBO + FOR Combined(n=55)REV + FOR Sequential(n=63)REV + FORCombined(n=62)
Current smoker4 (12.5)(n=32)1 (3.6)(n=28)1 (2.7)(n=37)1 (2.8)(n=36)
Former smoker3 (11.1)(n=27)5 (18.5)(n=27)2 (7.7)(n=26)4 (15.4)(n=26)
GOLD 3/42 (10.0)(n=20)1 (5.3)(n=19)2 (8.0)(n=25)0(n=25)
Aged ≥65 years4 (14.3)(n=28)5 (17.9)(n=28)2 (8.7)(n=23)4 (17.4)(n=23)
Aged <65 years3 (9.7)(n=31)1 (3.7)(n=27)1 (2.5)(n=40)1 (2.6)(n=39)
Current ICS use3 (20.0)(n=15)2 (14.3)(n=14)0(n=13)1 (7.7)(n=13)
No current ICS use4 (9.1)(n=44)4 (9.8)(n=41)3 (6.0)(n=50)4 (8.2)(n=49)
Reversible to ipratropium4 (12.1)(n=33)4 (13.3)(n=30)2 (6.7)(n=30)2 (6.9)(n=29)
Not reversible to ipratropium3 (11.5)(n=26)2 (8.0)(n=25)1 (3.0)(n=33)3 (9.1)(n=33)
Trough FEV1 from baseline, LS change (mL)Trough FEV1 from baseline, LS change (mLPBO + FOR Combined(n=59)REV + FOR Sequential(n=63)REV + FORCombined(n=63)
Current smoker30.5 (42.4)(n=27)−9.5 (42.9)(n=26)205.3 (41.3)(n=32)159.1 (41.0)(n=33)
Former smoker75.6 (41.6)(n=27)77.6 ( 41.6)(n=27)98.7 (42.8)(n=25)63.1 (42.3)(n=26)
GOLDb 3 and 475.1 (47.8)(n=19)65.3 (48.4)(=18)168.4 (47.9)(n=22)118.5 (47.2)(n=23)
Aged >65 years33.4 (43.4)(n=28)30.5 (43.4)(n=28)66.0 (47.3)(n=22)68.6 (46.7)(n=23)
Aged ≤65 years74.1 (43.0)(n=26)38.2 (43.5)(n=25)231.3 (38.7)(n=35)162.0 (38.5)(n=36)
Current ICS use-37.3 (57.5)(n=14)-19.47 (58.6)(n=13)96.3 (62.3)(n=11)128.2 (60.7)(n=12)
No current ICS use116.6 (33.7)(n=40)86.22 (33.7)(n=40)207.30 (31.5)(n=46)147.97 (31.3)(n=47)
Reversible to ipratropium45.7 (39.3)(n=30)30.0 (39.3)(n=30)253.5 (43.4)(n=27)170.5 (42.8)(n=28)
Not reversible to ipratropium67.2 (43.9)(n=24)45.5 (44.6)(n=23)79.6 (39.1)(n=30)75.1 (38.7)(n=31)
  • aAEs were collected from days 1 to 42. b2017 GOLD criteria. cFEV1 was collected in the morning at baseline and on days 21 and 42. n= evaluable n. AE, adverse event; FEV1, forced expiratory volume in 1 second; FOR, formoterol; GOLD, Global Obstructive Lung Disease; ICS, inhaled corticosteroids; LS, least squares; PBO, placebo; REV, revefenacin, SE, standard error.